Previously, there have been many devices disclosed that join and prevent disconnection of female and male couplers. Some of these devices are disclosed in U.S. Pat. Nos. 5,129,839—VanSkiver; 4,596,430—Olson; 4,206,961—Cifalde; 4,143,934—Siebert; 6,619,975—Bentley et al; 6,036,525—Alfis III; 4,723,822—Merdic; 4,643,505—House et al; and 5,593,312—McCracken.
However, none of the abovementioned devices have been applied or are suitable to applications for restraining couplers of percutaneous lead assemblies. Percutaneous lead assemblies include leads that are fed through a patient's epidermis and typically power active implantable medical devices. Preferably, these active implantable medical devices include rotary blood pumps such as the devices described in: U.S. Pat. No. 6,227,797—Watterson et al; and U.S. Pat. No. 6,866,625—Ayre et al.
Preferably, percutaneous lead assemblies require the external portion of the lead assembly to be at least partially restrained so as to restrict unnecessary movement of the assembly and the couplers, and none of the aforementioned restrainers or devices achieve this. Unnecessary movement or motion may occur normally during the use of the active implantable medical device or the assembly and may lead to the assembly becoming worn, damaged or accidentally disconnected. Typically, this wear or damage may occur when the percutaneous lead assembly rubs against the outer skin layer or epidermis of the patient. Also, accidental disconnection may occur because of the stresses experienced by the percutaneous lead assembly, when in use. Additionally, the motion of the percutaneous lead assembly, when in use, may accidentally activate the release mechanisms described in the prior art and lead to accidental disconnection of the couplers.
U.S. Pat. No. 4,579,120—MacGregor describes a device for restraining a percutaneous lead by means of a flexible, elastomeric disc having a surface for contacting and conforming to the body of the patient. This device, that does not utilise couplers, has a major disadvantage. If the percutaneous lead is damaged, there is no way a clinician may easily replace the external portions of the lead without surgically cutting the lead from the patient's body. Furthermore, the device does not provide a sufficient strain relief necessary when the percutaneous lead is exposed to normal “wear and tear” conditions.
Whilst there are also many devices for coupling medical devices by utilising couplers, such as cannulation for drug delivery and the like, such couplers are not adapted for restraining these devices against the patient's body.
None of the aforementioned restraining devices are adapted for minimal wear and damage to couplers of a percutaneous lead assembly, nor are they suited to restricting the disconnection of such couplers.
The present invention aims to or at least address or ameliorate one or more of the disadvantages associated with the abovementioned restraining device prior art.